Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS released its FY 2022 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Rates Proposed Rule. Read more about the rule and other news below.
I. Regulations, Notices & Guidance
On April 26, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases; Draft Guidance for Sponsor-Investigators. FDA is publishing this draft guidance to help sponsor-investigators with developing the nonclinical information that FDA recommends to support an investigational new drug application (IND) for certain individual
Peter L. Slavin â79 will step down as president of Massachusetts General Hospital, a role he has held for the past 18 years, he announced in a message to hospital affiliates Wednesday morning.
Under Slavinâs leadership since 2003, MGH twice ranked as the top hospital in the U.S. News & World Report âBest Hospitalsâ list, established numerous research programs including the Ragon Institute and the Center for Clinical Data Science, and spearheaded initiatives to combat racial and ethnic disparities in care.
Slavinâs departure follows that of former Brigham and Womenâs Hospital president Elizabeth G. âBetsyâ Nabel â who stepped down from her position last month. MGH and Brigham and Womenâs form the core of the Mass General Brigham hospital network, known as Partners HealthCare until 2020.
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Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS announced additional funding to support the 2021 Special Enrollment Period (SEP) for Marketplace health coverage. Read more about the announcement and other news below.
I. Regulations, Notices & Guidance
On March 4, 2021, the Food and Drug Agency (FDA) issued guidance entitled,
COVID-19 Container Closure System and Component Changes. FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of post-approval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new
340B: 266 House Legislators Want Fines for Drug Companies
Two hundred sixty-six members of the House of Representatives have told the Department of Health and Human Services that HHS should fine drug companies that deny 340B discounts to hospitals for drugs dispensed by contract pharmacies and to make drug companies pay hospitals back for discounts that were withheld. The letter says it’s the long-held position of the Health Resources and Services Administration that drug companies must provide 340B discounts to hospitals and clinics that qualify, regardless of whether hospitals dispense the drugs themselves. The letter states there are no provisions in the statute that allow manufacturers to set conditions or impede access to 340B discounts.